Encapsulation of components into edible products

ABSTRACT

An edible matrix composition that has a chewable texture and that contains at least one encapsulated component is obtained by admixing at least one plasticizer, and a ground, free-flowing particulate mixture which comprises at least one fat, at least one starch, and at least one sugar which have been mixed and heated without substanitially gelatinizing the starch. A chewable texture is obtained rather than a hard, glassy matrix because the starch is substantially ungelatinized. However, a flavorful product is obtained without destroying a heat sensitive encapsulant because the starch is admixed with ingredients comprising fat or oil and sugar and the mixture is heated to develop flavor at high temperatures prior to admixing with the heat sensitive encapsulant. The encapsulated component may be at least one biologically active component, pharmaceutical component, nutraceutical component, or microorganism. In preferred embodiments, the free-flowing mixture is obtained by grinding cookies. The free-flowing mixture, such as ground cookies and the plasticizer, such as oil and water are mixed with an encapsulant to obtain a formable dough or crumbly mass. The formable dough is shaped or formed into pieces or pellets and dried to a shelf-stable moisture content

This application is a 371 application of PCT/US99/04267 filed Mar. 23,1999 and is a continuation in part of application Ser. No. 09/233,443filed Jan. 20, 1999, and claims the benefit of provisional applicationNos. 60/079,060 filed Mar. 23, 1998, No. 60/103,700 filed Oct. 9, 1998and No. 60/109,696 filed Nov. 24, 1998.

FIELD OF THE INVENTION

The present invention relates to compositions, the use and themanufacturing of edible products, that contain encapsulated or embeddedcomponents, such as nutraceutical components, pharmaceuticals,biologically active components, and/or live microorganisms. The productsaccording to this invention are intended to be consumed either directlyas a food or they may be used as additions to food, such as topicalapplications or in beverages. They are not intended to undergoadditional severe processing that might thermally or mechanicallydestroy the encapsulant. The products made according to this inventionexhibit eating qualities, such as a chewable texture, as it occurs infor example streusel or chewable vitamin pills, and a cookie-like taste.

BACKGROUND OF THE INVENTION

Encapsulation of food components is described in Encapsulation andControlled Release of Food Ingredients, edited by S. J. Risch and G. A.Reineccius, ACS Symposium Series 590 (1995). U.S. Pat. No. 5,183,690 toCarr, et. al. describes a continuous extrusion process usingstarch-based material to encapsulate components. The resulting productsare in the form of particulates, which have gelatinized starch as acontinuous domain, in which discontinuous domains of biologically activecore material is entrapped.

Encapsulation of heat sensitive components, for example nutraceuticalcomponents, such as for example microorganisms, into matrixes that areedible, is generally difficult for a number of reasons. First,conventional encapsulation processes which expose matrix material andencapsulants to high temperatures, causes thermal destruction or loss ofencapsulant. Thus, either large overdoses of encapsulant, which would bevery expensive, would be required, or the encapsulant would not sustainthe encapsulation process at all. Second, if the encapsulant can beencapsulated into a matrix under sufficiently low temperatures, theresulting product is a solid, that is characterized as substantiallyhard and glass-like. The hardness and glassiness is caused by cooking astarch-based material with a sufficient amount of water to gelatinizethe starch and subsequently separating the starch-based materials intodiscrete particles and drying them so that the water content of thestarchy mass is sufficiently low. However, the temperature at which theparticles are consumed, or the eating temperature, is generally lowerthan 50° C., which is far below the glass transition temperature, T_(g),of the cooked, dried starch. Therefore, products of this kind exhibit adense and glassy, very hard texture, that may be very suitable toencapsulate components. However, when chewed they cause severe problems,because they are not chewable and exhibit a texture similar to that ofuncooked rice or pasta. They can therefore be only swallowed asmicrotablets without chewing. They could also be used as dense pelletsfor a variety of processing applications, where a controlled release ofthe heat sensitive encapsulant is desired. The physical hardness of theproducts and their mechanical stability are advantageous for manyprocessing applications. However, chewing or masticating of theseproducts would be very unpleasant and their incorporation into otherfood products is not practical.

The present invention provides an edible product, that is chewable, hasa pleasant taste and texture and contains encapsulated components,particularly nutraceutical, pharmaceutical or biologically activecomponents. The chewable product can be used either as a food productitself, or as part of a food product, i.e. as an ingredient or as atopping, that may be applied to surfaces of food. A main physicalcharacteristic of the product made according to the present invention isthat the product is substantially less hard than foods products such asuncooked rice and raw pasta. The chewable, flavorful product can beeaten either alone as a food itself, or for example as medical food, asfood having a pharmaceutical effect, as a dietary supplement, or incombination with other foods, such as a topping or in pasty foods orbeverages.

SUMMARY OF THE INVENTION

The present invention provides a product that contains an encapsulatednutraceutical component, pharmaceutical component, biologically activecomponent, or live microorganisms, or a combination thereof. Inpreferred embodiments, the product contains an encapsulatedmicroorganism. The products of the present invention contain the one ormore encapsulants in a pleasantly tasting and chewable surroundingmatrix.

The matrix composition of the present invention comprises a plasticizer,such as oil and/or water, and a substantial amount of a free flowingmixture of at least one fat, one starch and one sugar, that arepreprocessed, i.e. mixed and heat treated so as to substantially preventgelatinization of starch and to provide a pleasantly tasting product. Anexample of the free flowing mixture is fine ground-up cookies having aparticle size of 100% smaller than about 1 mm.

The mixture may contain additional components to enhance preprocessingor to improve sensory attributes, such as flavor, sodium chloride,nonfat dry milk, whey protein, high fructose corn syrup, dextrins, andleavening agents, as well as other components known to those skilled inthe art of producing pleasantly tasting cookie type products.

The matrix may further comprise components that either facilitateprocessing, or mask the unpleasant taste of the encapsulants, or preventexposure to oxygen or air, or which enhance the sensory attributes ofthe final product. These components include, for example, lipids, suchas oils or fats, chocolate liquor, chocolate, cocoa powder, compoundcoatings, flavors, concentrated fruit juice, or particulates, such, asfor example ground nuts or almonds. The water may be pH adjusted toobtain a good tasting product.

A chewable texture is obtained rather than a hard, glassy matrix becausethe starch is substantially ungelatinized. However, a flavorful productis obtained without destroying a heat sensitive encapsulant because thestarch is admixed with ingredients comprising fat or oil and sugar andthe mixture is heated to develop flavor at high temperatures prior toadmixing with the heat sensitive encapsulant.

In accordance with the method of the present invention, a productcontaining a substantial amount of a free-flowing material in which thestarch component is substantially ungelatinized may be obtained bygrinding a baked product, such as cookies or cookie-type products, toobtain a free-flowing particulate mixture or flour. The reduced particlesize facilitates the formation of a dough or crumbly mass upon mixing ofthe free-flowing mixture with a plasticizer such as water and/or oil. Inembodiments of the invention, the particle size of a cookie-type productor cookies may be reduced to obtain a dry, free-flowing particulatemixture having a particle size of about 100% smaller that 1 mm.

Admixing of the free-flowing mixture, such as ground-up cookie flour,with at least one plasticizer such as water and/or oil and theencapsulant with the other components to obtain a dough or crumbly massmay be performed continuously using an extruder or continuous mixer. Thedough or crumbly mass may be formed or pressed into discrete particles.Moisture may be removed from the particles to an amount sufficiently lowso as to obtain a sufficient shelf life. The products made according tothe invention exhibit a granular, crumbly structure having a pleasanttaste and are chewable.

DETAILED DESCRIPTION OF THE INVENTION

An edible, starch-based matrix composition that contains at least oneencapsulated component and that is chewable, rather than hard and glassyis obtained from a ground pre-processed, free-flowing particulatemixture and at least one plasticizer without substantially gelatinizingthe starch. The free-flowing mixture may be obtained by admixing andheating at least one fat, at least one starch, and at least one sugarwithout substantially gelatinizing the starch. The encapsulatedcomponent may be one or more biologically active components,pharmaceutical components, nutraceutical components, microorganisms, ormixtures thereof. In embodiments of the invention, the free-flowingmixture may be obtained by baking a mixture of said at least one fat, atleast one starch, and at least one sugar without substantiallygelatinizing said at least one starch to obtain a baked product and thengrinding the baked product to obtain the free-flowing mixture. Inpreferred embodiments, the free-flowing mixture is at leastsubstantially ground cookies or a flour obtained by grinding cookies.

A key requirement of the free-flowing mixture, such as ground-up cookieflour or ground-up cracker flour is that its starch component, which mayoriginate from grain sources such as wheat, oats, barley, corn, rye, orother grains or potatoes or other roots, is substantially notgelatinized. Production of a free-flowing mixture without substantiallygelatinizing starch can be accomplished in known manner by any oneordinarily skilled in the art of making cookies or cookie-type products.If the free-flowing mixture contained substantial amounts of gelatinizedstarches, the process would result in products that after drying exhibitsubstantial glassiness, hardness and thus a mechanical stability that isundesirable. The substantially gelatinized, glassy, hard products wouldnot exhibit desirable sensory attributes.

If the matrix composition was made from a pasta flour, such as forexample semolina, the mechanical characteristics of the final productwould be similar to commonly known uncooked pasta and would beundesirably hard for direct consumption. Products made from soft wheatflour that has not been cooked or processed into a cookie-type product,would exhibit inferior taste and would be undesirable for directconsumption.

A cookie-type product for use in the present invention may be made byknown conventional cookie production processes. As is well known, cookieproduction comprises admixing of at least fat and sugar, and addingflour to the premixed sugar/fat mix to obtain a cookie dough.Optionally, minor ingredients and water can be added to facilitatemachining of the dough, and to obtain a typical texture and taste of thefinal cookie. The cookie dough is formed into individual pieces andbaked under conventional baking conditions. The baking is generallyperformed above the gelatinization temperature of starch, but the starchis not substantially gelatinized because sufficient amounts of water arenot accessible to the starch at the elevated temperatures. However, thebaking helps to develop flavor, through Maillard reactions for example,and develops a leavened, crumb structure.

Conventional or commercially available cookie or other baked goodformulations and ingredients may be used to produce the free-flowingmixtures employed in the present invention. Examples of cookies andcookie-like products which may be ground for use in the presentinvention are butter cookies, sugar cookies, graham crackers, chocolatechip cookies, oatmeal cookies, sugar wafers, almond cookies, chocolatecookies, vanilla wafers, mixtures thereof, and the like.

Exemplary amounts of ingredients which may be used to obtain afree-flowing mixture are: from about 10% by weight to about 40% byweight fat, from about 20% by weight to about 40% by weight sugar, andfrom about 45% by weight to about 75% by weight flour, preferably wheatflour, based upon the total weight of the fat, sugar and flour in thefree-flowing mixture.

Conventional minor and other conventional cookie ingredients, which maybe included in the free-flowing mixture, such as ground cookies, are forexample, high fructose corn syrup, maltodextrins, corn syrup, dextrose,maltose, modified or unmodified starches, eggs, leavening agents such assodium bicarbonate, ammonium bicarbonate baking soda, and calciumphosphate, non-fat dry milk, full-fat dry milk, whey proteins, gluten,natural or artificial flavors, insoluble and soluble fibers, such asinulin, hydrocolloids, such as guar gum or gum arabic, dry eggs, salt,nutrients, and emulsifiers such as mono- and diglycerides.

In embodiments of the invention, ground cookies employed as afree-flowing mixture in the present invention may comprise from about 8%by weight to about 40% by weight shortening or fat, from about 15% byweight to about 40% by weight sugar, and from about 20% by weight toabout 75% by weight flour, based upon the weight of the ground cookies.

In embodiments of the invention, after baking and cooling, a cookieproduct or a commercially available cookie may be ground up into a flouror powder or meal using a conventional mill or other grinding apparatus.The particle size distribution may preferably be similar to that of aflour. The ground flour has a preferred particle size of 100% smallerthan 1 mm to form a continuous dough phase. In embodiments of theinvention, the ground, particulate free-flowing mixture may have aparticle size distribution of 100% less than 10 mm. However, with a muchcoarser particle size, (for example if the majority of the particleswere 5 mm) the ground product would not yield a uniform dough and wouldproduce a granular, nonhomogeneous phase. Much finer powders, forexample 100% less than 50 micron would create processing difficulties,such as feeding problems, dusting, and caking to processing surfaces. Inpreferred embodiments at least a substantial portion of the ground,free-flowing particulate mixture has a particle size distribution offrom about 50 microns to about 1 mm.

Another requirement of the free-flowing mixture such as ground cookiesis that its starch component is substantially ungelatinized. This may beaccomplished, during the process of cookie making for example, by mixingand/or coating the starch-containing components with fat before addingoptional moisture. Another possibility is to entrap added moisture infat and prevent moisture access to the starch in the flour. At leastsubstantially ungelatinized starch in the final ground cookie or otherfree-flowing mixture tends to resist subsequent gelatinization whenmixed with water. In embodiments of the invention the starch in thefree-flowing mixture, such as ground cookies, and in the matrixcompositions of the present invention has a degree of starchgelatinization of less than about 50%, preferably less than about 30%,preferably less than about 15%, as measured by differential scanningcalorimetry (DSC).

The free-flowing mixture, such as ground cookies is used in an effectiveencapsulating amount. In embodiments of the present invention, thefree-flowing mixture content, such as the cookie or cracker flourcontent of the particles may be at least about 10% by weight, generallyat least about 30% by weight, for example from about 60% by weight toabout 95% by weight, based upon the weight of the edible, chewablematrix composition. The amount of free-flowing mixture, such as groundcookies employed may depend upon the desired texture and the plasticizeremployed. For example, if water is employed as the plasticizer,generally the free-flowing mixture content of the chewable matrixcomposition is higher, for example, at least about 40% by weight,because water is removed during drying to obtain a shelf stable product.If the plasticizer employed does not have to be removed to obtain ashelf-stable product, the free-flowing mixture content may be lower. Forexample, if the plasticizer is a fat which is at least substantiallysolid at room temperature, the free-flowing mixture content may be atleast about 10% by weight, based upon the weight of the edible, chewablematrix composition.

Plasticizers employed in the present invention may be any edible orconsumable liquid which enables the formation of a substantiallyhomogeneous cohesive, plasticized, viscoelastic, formable mixture, doughor crumbly mass. Exemplary of plasticizers which may be used are water,an aqueous-based composition such as a sugar solution, juice, alcohol,glycerol, and sorbitol, oils, melted shortenings or fat, and mixturesthereof.

The amount of liquid plasticizer, such as water and/or oil, shouldgenerally be sufficient to obtain a formable mixture or dough at asufficiently low temperature and under sufficiently low shear conditionsso as to avoid substantial mechanical or thermal destruction of thefree-flowing mixture or encapsulant. Exemplary total amounts ofplasticizer, such as oil and/or water, used to form a dough or crumblymass may range up to about 90% by weight, generally from about 10% byweight to about 70% by weight, for example from about 20% by weight toabout 45% by weight, based upon the total weight of the free-flowingmixture, such as ground cookies, and the added plasticizer used to formthe dough or crumbly mass.

If water is employed as a plasticizer, it may generally be used in anamount of less than or equal to about 25% by weight, based upon thetotal weight of the free-flowing mixture and added water to obtain aformable, extrudable dough. Higher amounts are less desirable, becausemore drying may be needed to obtain a shelf-stable product. When anedible oil, shortening or fat is employed as a plasticizer, it maygenerally be used in an amount of up to about 90% by weight, preferablyup to about 20% by weight, most preferably up to about 10% by weight,based upon the total weight of the free-flowing mixture, such as groundcookies and the oil, shortening or fat.

Generally, higher amounts of the encapsulant component may beencapsulated in the matrix composition when an oil, shortening or fat isused as a plasticizer because generally higher amounts of oil may beemployed compared to the amount of water which may be employed. Use ofan oil or fat as a plasticizer in place of or in addition to water isadvantageous because the oil or fat in addition to facilitatingextrusion, also serves as a preencapsulation medium. The oil or fatprovides a protective coating on the free-flowing mixture, such asground cookies, and on the encapsulant. Also, the need for drying of thedough to obtain a shelf-stable moisture content is substantially reducedor eliminated when oil or fat is employed as a plasticizer. The additionof vegetable oil during mixing has been proven useful to obtain a smoothcontinuous dough phase and it facilitates forming of the dough intodiscrete particles.

Edible oils, shortenings or and fats which may be employed include thosederived from plant, animal, and marine sources such as vegetableshortening or oils, which include corn oil, safflower oil, soybean oil,and cotton seed oil, which may be hydrogenated, as well as edible fatsubstitutes. In embodiments of the invention, particularly where highlevels of oil or fat are employed, the melting point of the oil,shortening or fat should be sufficiently high so as to avoid separationof oil during extrusion. For example, the melting point of the oil,shortening or fat may be at least about 30° C., preferably at leastabout 37° C., most preferably at least about 40° C.

In embodiments of the invention, the formable mixture or dough may havea total plasticizer content, such as water and/or oil, of up to about90% by weight, generally from about 10% by weight to about 50% byweight, for example about 15% by weight to about 25% by weight. Thetotal plasticizer content may include water supplied by any liquidencapsulant component and additional plasticizer, such as added water,glycerol, sorbitol or a combination thereof or any other liquids, suchas fruit juice, that enables the formation of a dough. When water or lowmelting point oils are employed at high levels, for example a moisturecontent well above 50%, a thin, low viscosity dough may result. The lowviscosity dough may either not be formable or the drying efforts wouldbe unnecessarily high. Substantially lower moisture contents, such aswell below 5% may result in a dry product, which would be too fragileafter forming and would fall apart. It may also generate frictional heatduring extrusion forming which would be detrimental to the heatsensitive encapsulant. The water may be mixed with organic acids orfruit juice to adjust pH and to obtain a pleasant flavor in the finalproduct.

In embodiments of the invention, where for example, removal ofplasticizer is not needed to obtain a shelf-stable matrix composition,the plasticizer content of the edible, chewable matrix composition maybe at least substantially the same as the plasticizer content of theformable mixture, dough or crumbly mass. For example, in embodiments ofthe invention when an oil, shortening or fat is employed as aplasticizer, the plasticizer content of the edible, chewable matrixcomposition may be up to about 90% by weight, for example from about 10%by weight to about 50% by weight, based upon the weight of the matrixcomposition.

The liquid plasticizer content of any liquid encapsulant componentutilized may be at least about 35% by weight, generally at least about50% by weight, for example from about 65% by weight to about 90% byweight, based upon the weight of the liquid encapsulant component.

For example, an aqueous dispersion of Lactobacillus acidophilus may havea moisture content of about 70% by weight and an encapsulant content(Lactobacillus acidophilus) of about 30% by weight. The 70% moisturecontent stemming from the acidophilus dispersion may be used as aplasticizer. The ratio of the free-flowing mixture to moisture stemmingfrom the aqueous encapsulant liquid may be about 3:1 to enable theformation of a homogeneous dough. Vegetable oil may be added to delaypenetration of water into the matrix and delay the release of themicroorganism. The encapsulation of sensitive liquid components into amatrix to obtain discrete shelf-stable particles is disclosed in U.S.patent application Ser. No. 09/233,443 filed Jan. 20, 1999 in the nameof Bernhard H. van Lengerich for “Encapsulation of Sensitive LiquidComponents into a Matrix to Obtain Discrete Shelf-stable Particles,” thedisclosure of which is herein incorporated by reference in its entirety.

Edible, plasticizable matrix components which form a glassy matrix, suchas gelatinized starches, and other ingredients may be included in thechewable, matrix compositions of the present invention provided they donot adversely affect the chewable texture of the matrix composition.Gelatinized starches may, for example, be included in an amount up toabout 30% by weight of the free-flowing mixture, such as ground cookies.

Examples of optional, edible, plasticizable matrix materials which areplasticizable at low temperatures by the plasticizer component may be aplasticizable biopolymer such as a carbohydrate, such as a starch orcyclodextrin, polyethylene glycol, pentosans, hydrocolloids such ascarragenan, alginates, or gum arabic, wheat gluten, such as vital wheatgluten or isolated gluten, and mixtures thereof. Exemplary starcheswhich may be used are native or modified starches or pregelatinizedstarches derived from corn, wheat, rice, potato, tapioca, or highamylose starch. Sources of starch which may be used also include floursfrom grains such as corn, wheat, durum wheat, rice, barley, oat, or rye,and mixtures thereof. In preferred embodiments, finely ground orpowdered cookies or crackers, or ground cookie-like or cracker-likeproducts are employed with substantially no additional, plasticizable,gelatinized matrix materials.

Additional matrix components which may be used include solid componentswhich are substantially non-plasticizable at temperatures lower than thedecomposition temperature of the heat sensitive encapsulant. Exemplaryof such optional, substantially non-plasticizable matrix components areat least substantially non-gelatinized starch, carbohydrates which havea lower molecular weight than starches, fiber, or other inert materials,such as cellulose, or hemi-cellulose. The lower molecular weight matrixcomponents tend to dissolve more readily than does starch and increasethe penetrability or porosity of the matrix. As a result, access by thedissolution medium, such as water or acid, to the encapsulant isincreased thereby permitting quicker release of the encapsulant from thematrix material. Examples of carbohydrates other than starch which maybe used are sugars, such as mono- and di-saccharides, and starchhydrolyzate products such as dextrins or syrups with dextrose equivalentvalues (DE values) ranging from about 2 to about 99, or from about 5 to98, and mixtures thereof

Additional ingredients which may be used to control the releaseproperties of the final product may be a hydrophobic agent for slowingdown the rate of release of the encapsulant. Exemplary of componentswhich may be added to affect the hydrophobicity of the matrixcomposition include fats, oils, waxes, fatty acids, emulsifiers, such asmono- or di-glycerides, modified starches from plant sources thatpossess hydrophobic properties that are obtained via either physical orchemical modification, and mixtures of hydrophobic components. Plantlipids or synthetic lipids with melting points up to about 65° C. may,for example, be employed as a hydrophobic agent. The hydrophobiccomponents increase the hydrophobicity of the matrix and help to preventor delay penetration of water or gastric juice into the matrix byrepelling water or aqueous acids, thereby delaying the release of theencapsulant into the surrounding media.

Additional components which may be used to delay or prevent a fastrelease of the encapsulant from the matrix are components or agentswhich have a high water binding capacity. The agents may have a waterbinding capacity or water holding capacity which is greater than thewater binding capacity of the free-flowing mixture, such as groundcookies. The high water binding capacity component may bind water whichpenetrates the particles, or prevent the water from dissolving thematrix, thereby preventing or delaying the release of the encapsulantfrom the matrix. Exemplary of high water binding capacity agents whichmay be used in the present invention are protein from animal sourcessuch as gelatin, casein, and protein from sources such as wheat, soy,corn, or other grains, and hydrocolloids such as carrageenans,alginates, xanthan gum, gum arabic, guar flour or guar gum, agar,tragacanth, karaya, locust bean gum, pectin, soluble fiber, insolublefiber and the like. Exemplary proteins from grains which may be used aregluten, vital wheat gluten, zein, and soy protein concentrate. Theproteins from plant sources may also be used to increase the tolerableaddition of lipids within the matrix composition and thereby indirectlyincrease the hydrophobicity of the matrix. The high water bindingcapacity components may be used alone or mixtures thereof may beemployed.

Process compatible additional components to facilitate processing, or toimprove sensory attributes such as the taste, texture, aroma, color,appearance, or hydration behavior of the final pellets which may beemployed include: flavors, sodium chloride, nonfat dry milk, wheyprotein, high fructose corn syrup, leavening agents, lipids, such asoils or fats, chocolate liquor, chocolate, cocoa powder, compoundcoatings, concentrated fruit Juice, or particulates, such as ground nutsor almonds. The water may be pH adjusted to obtain a good tastingproduct. The addition of vegetable oil during mixing has been founduseful to obtain a smooth continuous dough phase and it facilitatesforming of the dough and cutting into discrete particles withoutsticking.

The additional components or ingredients, such as those used to controlthe rate of release of the encapsulant may be used in amounts up toabout 70% by weight, preferably from about 5% by weight to about 50% byweight, most preferably from about 10% by weight to about 35% by weight,based upon the weight of the free-flowing mixture, such as ground-upcookies.

The encapsulant may be in solid or liquid form for inclusion in thematrix compositions and encapsulated products of the present invention.Active components which may be encapsulated or embedded in the matrixesin accordance with the present invention include pharmaceuticalcompositions or compounds, nutraceutical compositions or compounds,nutritional components, or biologically active components, flavorants,and fragrances.

The pharmaceutical compounds or compositions and biologically activecompositions may, for example, include antibiotics, analgesics,vaccines, antiinflammatory agents, antidepressants, anti-viral agents,anti-tumor agents, enzyme inhibitors, formulations containingzidovudine, macromolecular polypeptides, aromatic nitro and nitrosocompounds and their metabolites useful as anti-viral and anti-tumoragents, HIV protease inhibitors, viruses, and steroids, compositions topromote growth such as hormones, or other growth stimulating agents,mixtures thereof, and the like.

Nutraceutical components may include components which promote health orprevent disease or enhance well-being such as antioxidants,phytochemicals, hormones, vitamins such as Vitamins A, B1, B2, B6, B12,C, D, E, K, pantothenate, folic acid, pro-vitamins, minerals such ascalcium, selenium, magnesium salts, available iron, and iron salts,microorganisms such as bacteria, such as live lactobacilli, fungi, andyeast, prebiotics, probiotics, trace elements, essential and/or highlyunsaturated fatty acids such as omega-3 fatty acids, and mid-chaintriglycerides, nutritional supplements, enzymes such as amylases,proteases, lipases, pectinases, cellulases, hemicellulases,pentosanases, and phytases, pigments, oligopeptides, dipeptides, andamino acids, and mixtures thereof.

Exemplary of the active components which may be encapsulated or embeddedin accordance with the present invention are: acepromazine,acetaminophen, acetohexamide, acetohydroxamic acid, acetylcholine,acetylcysteine acyclovir, albendazole, alclometasone dipropionate,allopurinol, alprazolam, alprostadil, amcinoide, amantadine,amdinocillin, amikacin amiloride, aminocaproic acid, aminophylline,aminosalicylate, aminosalicylic acid, amitriptyline hydrochloride,ammonium chloride, amobarbital, amodiaquine hydrochloride, amoxapine,amoxicillin, amphetamine sulfate, amphotericin, ampicillin amprolium,acetazolamide acetyldigoxin, acetylsalicylic acid, anileridine,anthralin, antipyrine, antivenin, apomorphine, apraclonidine, ascorbicacid, aspirin, acromycin atropine, amoxycillin anipamil, azaperoneazatadine maleate, azathioprine, azithromycin, aztreonam, bacampicillin,bacitracin, baclofen, barium salts, beclomethasone diproionate,belladonna extract, bendroflumethiazide, benoxinate hydrochloride,benzethonium chloride, benzocaine, benzonatate benzthiazide, benztropinemesylate, betaine, betamethasone, betaxolol, betanechol chloride,biotin, biperiden, bisacodyl, bismuth, botulism antitoxin, bromocriptinemesylate, bromodiphenhydramine hydrochloride, bumetanide, bupivacaine,busulfan butabarbital sodium, butalbital, combinations of butalbital,caffeine and aspirin and codeine, beta-carotene, calcifediol, calciumcarbonate, calcium citrate, calcium salts, candicidin, captopril,carbachol, carbamazepine, carbenicillin indanyl sodium, carbidopa,carbinoxamine maleate, carboprost tromethamine, carboxymethyl cellulose,carisoprodol, casanthranol, cascara, castor oil, cefaclor, cefadroxil,cefamandole nafate, cefazolin, cefixime, cefoperazone, cefotaxime,cefprozil, ceftazidime, cefuroxime axetil, cephalexin, cephradine,chlorambucil, chloramphenicol, chlordiazepoxide, chloroquine phosphate,chlormadinone acetate, chlorothiazide, chlorpheniramine maleate,chloroxylenol, chlorpromazin, chlorpropamide, chlorprothixene,chlorprothixene, chlortetracycline bisulfate, chlortetracyclinehydrochloride, chlorthalidone, chlorzoxazone, cholecalciferol, choleravaccine, chromic chloride, chymotrypsin, cimetidine, cinoxazin,cinoxate, ciprofloxacin, cisplatin, clarithromycin, clavulanatepotassium, clemastine fumarate, clidinium bromide, clindamycinhydrochloride, -palmitate and -phosphate, clioquinol, clofazimine,clofibrate, clomriphene citrate, clonazepam, cinnarizine, clonidinehydrochloride, clorsulon, clotrimazole, cloxacillin sodium,cyanocobalamin, cocaine, coccidioidin, cod liver oil, codeine,colchicine, colestipol, corticotropin, corisone acetate, cyclacillin,cyclizine hydrochloride, cyclobenzaprine hydrochloride,cyclophosphamide, cycloserine, cyclosporine, cyproheptadinehydrochloride, cysteine hydrochloride, danazol, dapsone, dehydrocholicacid, demeclocycline, desipramine, desoximetasone, desoxycorticosteroneacetate, dexamethasone, dexchlorpheniramine maleate, dexpanthenol,dextroamphetamine, dextromethorphan, diazepam, diazoxide, dibucaine,dichlorphenamide, dicloxacillin sodium, dicyclomine, dienestrol,diethylpropion hydrochlorid, diethylstilbestrol, diflunisal, digitalis,dicoumarol, digitoxin, digoxin, dihydroergotamine, dihydrostreptomycin,dihydrotachysterol, dihydroxyaluminium amino acetate, dihydroxyaluminiumsodium carbonate, diltiazem hydrochloride, dimenhydrinate, dimercaprol,diphenhydramine hydrochloride, diphenoxylate hydrochloride, diphteriaantitoxin, dipyridamole, disopyramide phosphate, disulfiram, dobutaminehydrochloride, docusate calcium, docusate sodium, dopaminehydrochloride, doxepin hydrochloride, doxycycline, doxycycline hyclate,doxylamine cuccinate, dronabinol, droperidol, drotaverine,dydrogesterone, dyphylline, guaifenesin, enalapril maleate, analaprilat,ephedrine, epinephrine, equilin, ergocalciferol, ergoloid mesylates,ergonovine maleate, ergotamine tartrate, erythrityl tetranitrate,erythromycin, estradiol, estriol, estrogene, estrone, estropipate,ethcrynic acid, ethambutol hydrochloride, ethchlorvynol, ethinylestradiol, ethionamide, ethopropazine hydrochloride, ethotoin,ethynodiol diacetate, etidronate disodium, etoposide, eugenol,famotidine, fenoprofen, ferrous fumatate, ferrous gluconate, ferroussulfate, flucytosine, fludrocortisone acetate, flunisolide, fluocinoloneacetonide, fluocinonide, fluorescein sodium, fluorometolone,fluorouracil, fluoxymesterone, fluphenazine, flurandrenolide, flurazpam,flurbiprofen, folic acid, furazolidone, flunitrazepam, furosemide,gemfibrozil, gentamicin, gentian violet, glutarate, glutethimide,glycopyrrolate, chorionic gonadotropin, gramicidin, griseofulvin,guaifenesin, guanabenz, guanadrelsulfate, halazone, haloperidol,haloprogin, halothane, heparin calcium, hepatitis virus vaccine,hetacillin potassium, hexylresorcinol, histamine phosphate, histidine,homatropine, histoplasmin, hydralazine hydrochloride,hydrochlorothiazide, hydrocodone bitartrate, hydrocortisone,hexobarbital, hydroflumethiazide, hydromorphone hydrochloride,hydroquinone, hydroxocobalamin, hydroxyamphetamine, hydroxychloroquinesulfate, hydroxyprogesterone caproate, hydroxyurea, hydroxinehydrochloride, hydroxine pamoate, hyoscyamine, hyoscyamine sulfate,ibuprofen, ifosfamide, imipramide, imipramide hydrochloride, indapamide,indomethacin, insulin, inulin, iocetamid, iodoquinol, iohexol,iopamidol, ipecac, ipodate calcium, ipodate sodium, isocarboxacid,isoetharine hydrochloride, isoflurane, isoniacid, isopropamide iodine,isoproterenol hydrochloride, isosorbide dinitrate, isotretenoin,isoxsuprine hydrochloride, kanamycin sulfate, ketoprofen, ketoconazole,labetalol hydrochloride, lanolin, leucine, leucovorin calcium,levamisole hydrochloride, levocarnithine, levodopa, levonorgestrel,levorphanol tartrate, levothyroxine sodium, lidocaine, lincomycinhydrochloride, lindane, liothyronine sodium, liotrix, lisinopril,lithium carbonate, loperamide hydrochloride, loracarbef, lonetil,lorazepam, lovastatin, loxapine, lysine, mafenide acetate, magaldrte,magnesium carbonate, magnesiumchloride, magnesium gluconate, magnesiumoxide, other magnesium salts, malathinon, manganese salts, manganese,maprotiline hydrochloride, mazindol, measle virus vaccine, mebendazole,mebrofenin, mecamylamine hydrochloride, meclizine hydrochloride,meclocycline, meclofenamate sodium, medroxyprogesterone acetate,mefenamic acid, megestrol acetate, meglumine, melphalan, menadiol sodiumdiphosphate, menadione, menotropine, meperidine, mephenytoin,mephobarbital, meprednisone, meprobamate, mercaptopurine, mesoridazinebesylate, mestranol, metaproterenol sulfate, metaraminol bitartrate,methacycline hydrochloride, methadone hydrochloride, methamphetaminehydrochloride, methazolamide, methdilazine, methenamine, methicillinsodium, methimazole, methionine, methocarbamol, methotrexate,methoxsalen, methoxyflurane, methsuximide, methyclothiazide,methylbenzethonium chloride, methyldopa, methylergonovine maleate,methylphenidate hydrochloride, methylprednisolone, methyltestosterone,methysergide maleate, metoclopramide, metolazone, meoprolol tartrate,metronidazole, metyrapone, metyrosine, mexiletine hydrochloride,mexiletine hydrochloride, miconazole, minocycline hydrochloride,minoxidil, mitomycin, mitotane, molindone hydrochloride, monobenzone,morphine sulfate, mupirocin, medazepam, mefruside, methandrostenolone,methylsulfadiazine, nadolol, nafcillin, nafcillin sodium, nalidixicacid, nalorphine, naloxone, nandrolone decanoate, nandrolonephenpropionate, naproxen, natamycin, neomycin, neomycin sulfate,neostimine bromide, niacin, nitrofurantoin, nalidixic acid, nifedipine,nitrazepam, nitrofurantoin, nitroglycerine, nitromerson, nizatidine,nonoxynol 9, norethindrone, norethindrone acetate, norfloxacin,norgestrel, nortriptyline hydrochloride, noscapine, novobiocin sodium,nystatin, opium, oxacillin sodium, oxamniquine, oxandrolone, oxazepam,oxprenolol hydrochloride, oxtriphylline, oxybenzone, oxybutyninchloride, oxycodone hydrochloride, oxycodone, oxymetazolinehydrochloride, oxymetholone, oxymorphone hydrochloride, oxyphenbutazone,oxytetracycline, padimate, panreatin, pancrelipase, papain, panthenol,papaverin hydrochloride, parachlorophenol, paramethasone acetate,paregoric, paromomycin sulfate, penicillamine, penicillin, penicillinderivatives, pentaerythritol tetranitrate, pentazocine, pentazocinehydrochloride, pentazocine salts, pentobarbital sodium, perphenazine,pertussis, phenacemide, phenazopyridine hydrochloride, phendimetrazinetartrate, phenelzine sulfate, phenmetrazine hydrochloride,phenobarbital, phenophtalein, phenoxybenzamine hydrochloride,phentermine hydrochloride, phenylalanine, phenylbutazone, phenylephrinehydrochloride, phenylpropanolamine hydrochloride, physostigmine,phytonadione, pilocarpine, pimozide, pindolol, piperazine, piroxicamplicamycin, poliovirus vaccine inactivated, polycarbophil, polymycin bsulfate, polythiazide, potassium chloride, potassium citrate, potassiumcluconate, potassium iodine, potassium sodium tartrate, povidone iodine,pralidoxime chloride, pramoxine hydrochloride, pramezam, prazepam,praziquantel, prazosin hydrochloride, prazosin hydrochloride,prednisolone, prilocaine, primaquine, primidone, probenecid, probucol,procainamide hydrochiorid, procaine hydrochloride, procarbacinehydrochloride, prochlorperazine, prochlorperazine maleate, procyclidinehydrochloride, progesterone, proline, promazine, promazinehydrochloride, promazine, promethazine, promethazine hydrochloride,propafenone hydrochloride, propantheline, proparacaine hydrochloride,propoxycaine hydrochloride, propoxyphene hydrochloride, propoxyphenenapsylate, propanolol hydrochloride, propyliodone, propylthiouracil,propylthiouracil, protriptyline hydrochloride, pseudoephedrinehydrochloride, pumice, pyrantel pamoate, pyrazinamide, pyrethrumextract, pyridostigmine bromide, pyridoxine hydrochloride, pyrilaminemaleate, pyrimethamnine, pyroxylin, pyrvinium pamoate, phenacetin,phenytoin, prednisone, uinidine gluconate, quinidine sulfate, rabiesvaccine, racepinephrine ranitidine, rauwolfia serpentina, resorcinol,ribavirin, riboflavin, rifampin, ritodrine, rubella virus vaccine,saccharin, saccharin sodium, salicylamide, salicylic acid, salsalata,scopolamine, secobarbital sodium, selenius acid, selenium sulfate,sennasenrne, simethicone, sodium ascorbate, sodium bicarbonate, sodiumfluoride, sodium gluconate, sodium iodide, sodium lactate, sodiumnitrite, sodium ditroprusside, sodium salicylate, spironolactone,stannozolol, streptomycin, sucralfate, sulfacetamide, sulfadiazine,reserpine, sulfadioxine, sulfamerazine, sulfamethazine, sulfamethizole,sulfamethoxazole, sulfamethoxydiazine, sulfapyridin, sulfasalazine,sulfaperin, sulfathiazole, sulfisoxazole, sulfinpyrazone, sulindac,suprofen, stilains, tamoxifen citrate, temacepam, terbutaline sulfate,terfenadine, terpin, testolacton, testosterone, tolazamide, tolbutamide,tetracaine, tetracycline, tetrahydrocycline, theophylline,thiabendazole, thiamine hydrochloride, thiamin, thiamylal,thiethylperazine thimerosal, thioguanine, thioridazine hydrochloride,thistrepton, thiotepa, thiothixene, threonine, thyroid, ticarcillin,timolol, tioconazole, titaniumdioxide, tolazamide, tolbutamide,tolmetin, tolnaftate, trazodone hydrochloride, tretinoin, triacetin,triamcinolone, triamterene, triazolam, trichorfon, trichlormethiazide,trientine hydrochloride, trifluoperazine hydrochloride, triflupromazine,trihexyphenidyl hydrochloride, trimeprazine tartrate, trimethadione,trimethobenzamide hydrochloride, trimethoprim, trioxsalen,tripelennamine, triprolidine, trisulfapyrimidine, tropicamide, trypsin,tryptohan, tuberculin, tyloxapol, tyropanoate sodium, tyrosine,tyrothricin, thyrothricin bethamethasone, thiotic acid, sotalol,salbutamol, norfenefiine, silymarin, dihydroergotamine, buflomedil,etofibrate, indometacin, urea, valine, valproic acid, vancomycinhydrochloride, vasopressin, verapramil, vidarabine, vinblastine,vincristine, vitamins, warfarin, yellow fever vaccine, zinc acetate,zinc carbonate, zinc chloride, zinc gluconate, beta acetyl digoxin,piroxicam, haloperidol, ISMN, amitriptylin, diclofenac, nifedipine,verapamil, pyritinol, nitrendipin, doxycycline, bromhexine,methylprdnisolone, clonidine, fenofibrate, allopurinol, pirenyepine,levothyroxin, tamoxifen, metildigoxin, o-(beta-hydroxyethyl)rutoside,propicillin, aciclovir mononitrate, paracetamol, naftidrofuryl,pentoxiflline, propafenone, acebutolol, L-thyroxin, tramadol,bromocriptine, loperamide, ketotifen, fenoterol, cadobelisate,propanolol, enalaprilhydrogen maleate, bezafebrate, ISDN, gallopamil,xantinol nicotinate, digitoxin, flunitrazepam, bencyclane,dexapanthenol, pindolol, lorazepam, diltiazem, piracetam,phenoxymethylpenicillin, furosemide, bromazepam, flunarizin,erythromycin, metoclopramide, acemetacin, ranitidin, biperiden,metamizole, doxepin, dipotassium chloroazepate, tetrazepam, estramustinephosphate, terbutaline, captopril, maprotiline, prazosin, atenolol,glibenclamide, cefaclor, etilfrine, cimetidine, theophylline,hydromorphone, ibuprofen, pnimidone, clobazam, oxaceprol,medroxyprogesterone, flecainid, pyridoxal 5 phosphate glutaminate,hymechromone, etofylline clofibrate, vincamine, cinnarizine, diazepam,ketoprofen, flupentixol, molsimine, glibornuride, dimetinden, melperone,soquinolol, dihydrocodeine, clomethiazole, clemastine, glisoxepide,kallidinogenase, oxyfedrine, baclofen, carboxymethylcysteine,thioridazine, betahistine, L-tryptophan, murtol, bromelaine,prenylamine, salazosulfapyridine, astemizol, sulpiride, benzerazide,dibenzepine, acetylsalicylic acid, miconazol, nystatin, ketoconazole,sodium picosulfate, coltyramine, gemfibrocil, rifampicin, fluocortolone,mexiletin, amoxicillin, terfenadrin, mucopolysaccharide polysulfade,triazolam, mianserin, tiaprofenic acid, amezinium metilsulfate,mefloquine, probucol, quinidine, carbamazepine, L-aspartate, penbutolol,piretanide, aescin amitriptyline, cyproterone, sodium valproinate,mebeverine, bisacodyl, 5-aminosalicylic acid, dihydralazine, magaldrate,phenprocoumon, amantadine, naproxen, carteolol, famotidine, methyldopa,auranofine, estriol, nadolol, levomepromazine, doxorubicin,medofenoxate, azathioprine, flutamide, norfloxacin, fendiline,prajmalium bitartrate, lipid derivatives of phosphonatides, amphiphilicpolymers, adenosine derivatives, sulfated tannins, monoclonalantibodies, and metal complexes of water soluble texathyrin.

The amount of the active component or encapsulant which is incorporatedinto the products of the present invention may be such so as to provideor deliver an effective amount, such as a pharmaceutically effectiveamount or a nutraceutically effective amount of the active component atits intended location, such as the small intestine. Exemplary amounts ofthe active component or encapsulant which may be encapsulated orembedded into the matrix may be from about 1% by weight to about 85% byweight, preferably from about 3% by weight to about 50% by weight, mostpreferably from about 5% by weight to about 30% by weight, based uponthe weight of the free-flowing mixture, such as ground cookies. Inembodiments of the invention, the amount of the active component orencapsulant may be up to about 80% by weight, preferably up to about 50%by weight, most preferably up to about 20% by weight of the plasticizer,such as oil.

In embodiments of the invention, the encapsulants and/or the edible,chewable matrix composition may be coated to provide additionalprotection against oxygen, to provide mechanical stability againstabrasion, or to control release of the encapsulant without negativelyinfluencing the chewable texture of the matrix composition.Film-building or film-forming substances which may be used to coatencapsulants prior to admixing with the free-flowing mixture and priorto incorporation into the matrix include commonly used coatingmaterials. Exemplary of coating materials which may be employed arezein, pectin, shellac, gelatin, gluten, fats, oils, waxes, emulsifiers,native or modified starch, chitosan, chitin, and mixtures thereof Thesefilm-building or film-forming substances may also be used to coat theextruded, particulate chewable product. Pretreatment of the encapsulantby coating it with a film forming substance such as a high melting fator wax, or with an emulsifier such as glycerin monostearate, or thelike, tends to prevent unwanted interaction between an encapsulant andthe matrix. The encapsulants and the extrudate particles may be coatedwith film-forming amounts of the substances in aqueous or alcoholicsolutions, or oleaginous compositions. The encapsulants may bepre-encapsulated or pre-coated using any conventional encapsulation orcoating method which does not thermally destroy the encapsulant.

In embodiments of the invention pellets may be coated in a two stepcoating process. After discrete particles have been cut at an extrusiondie, the substantially undried pellets may be coated with a firstcomponent of a composite coat, such as an acetic-acid-chitosan-solution.After this step a second coat may be applied using a gel forming counterion, such as a polyphosphate solution, that causes the chitosan to geland form a chitin coat. The second ion may also be provided by a pectinand the resulting composite coat may then be a pectin-chitin coacervate.

The film-forming substances or coatings may also contain additionalcomponents that protect the particulates or pellets, or encapsulant,from the influence of light, such as titanium dioxide, or cocoa-basedproducts. The coatings may also contain anti-oxidants to protect thepellets or encapsulants from the influence of oxygen or air.

In accordance with embodiments of the present invention, the thicknessof the coating upon the encapsulant may be used to control the rate ofrelease of encapsulant once the dissolving media, such as water, reachesthe encapsulant. For example, increasing the thickness of the coating onthe encapsulant slows its rate of release into the media. Also,increasing the thickness of the coating on the extrudate or pelletdelays release of the encapsulant from the matrix material. Inembodiments of the invention, the amount of coating may range from about0.5% to about 50% by weight, based on weight of the total product,depending upon the desired release of the encapsulant.

In accordance with the method of the present invention, all of theingredients may be admixed together at a temperature of about 5° C. toabout 50° C., for example about 30° C. to obtain a formable mixture ordough. Mixing or dough temperatures substantially higher than about 50°C. are undesirable, because any fat or oil in the formula tends toseparate, or the heat sensitive substances to be encapsulated andembedded would be destroyed. Temperatures much lower than roomtemperatures, such as for example 0° C. are for most purposesimpractical but may be employed in special applications. In embodimentsof the invention, the temperature may be adjusted by external heating,below 50° C. so as to facilitate forming and enable cutting without thematerial sticking to the cutter.

In embodiments of the present invention, external heating of theingredients during their admixture is not required. For example, whereground cookies is used as the free-flowing matrix material, heating ofthe ground cookies and water to cook or gelatinize the starch is notneeded to obtain a formable dough which when dried to a shelf-stablemoisture content provides a chewable texture.

The admixing of the ingredients is conducted under low shear mixingconditions without substantially destroying or decomposing the matrixmaterial or encapsulant. An overall quantitative measure of the shearused inside an extruder, for example, is the specific mechanical energyinput. In embodiments of the present invention, the specific mechanicalinput during admixing of the ingredients to obtain a formable mixture ordough may be below about 150 Wh/kg, preferably below about 100 Wh/kg,and most preferably below about 50 Wh/kg.

In embodiments of the invention, the pressure under which the formablemixture or dough may be formed may range from about 1 bar to about 100bars. It is preferably formed into individual shapes at pressures ofabout 5 bars to about 60 bars.

The optional one or more additional ingredient or component, such as thehydrophobic component, or high water binding capacity component forcontrolling the release properties of the final product, may be dryblended or preblended with the free-flowing matrix material such asground cookies. In other embodiments of the invention, the additionalcomponent for controlling the release properties may be addedseparately.

The encapsulant may be added either during the dough mixing process orit may be added into the dough after it is produced. After addition andadmixing of the encapsulant, the dough may be compressed and shaped intodiscrete shapes.

In embodiments of the invention, a dough comprising all ingredients maybe made using conventional batch or continuous mixers. Subsequently, thedough, which may be a crumbly dough may be fed into a single screwextruder. The single screw extruder presses the dough against a dieplate and plasticizes the crumbs into a continuous dough phase which maythen be pressed through an extrusion die and subsequently cut intoindividual particulates.

In other embodiments of the invention, the dough can be madecontinuously and using a continuous mixer or extruder alone. Twin screwextruders or co-rotating twin screw mixers may be advantageously usedwhich enable the steps of continuously mixing the dough and subsequentlyextruding the dough through an extrusion die plate. Co-rotatingintermeshing twin screw extruders, such as those available from Buhler,Switzerland, Clextral France, Werner and Pfleiderer Germany, APV Englandor Wenger USA, or a Co-Kneader, available from Buss, Switzerland may beemployed.

For feeding solid components to an extruder, conventional solids feedingdevices such as a volumetric or gravimetric feeder may be used. Liquidinjection nozzles may be used for injecting liquid active components orsolutions, dispersions, emulsions or suspensions. In embodiments of theinvention, a side feeder and liquid injection nozzles may be employed.If an injection nozzle is used, the pressure for injecting the liquidencapsulant should be sufficiently higher than the pressure in theextruder so that the encapsulant can be injected into the extruderbarrel. For example, if the pressure of the plasticized mass inside theextruder is 10 bars, the injection pressure may be about 2 to about 5bars higher, i.e. 12 to 15 bars.

In embodiments where an encapsulant is pre-coated with a film-buildingmaterial or coating material, the coating material may be applied inconventional manner such as by spraying or enrobing using conventionalcoating equipment. Commercially available pre-coated active ingredients,such as precoated minerals or vitamins may be employed.

The admixing of the added active ingredients or encapsulants inside theextruder may be accomplished by using an appropriate extrusion screwconfiguration for achieving low shear mixing. For example, a combinationof alternating small pitch conveying elements with distributive mixingelements, that are staggered at an angle to each other for providingaxially oriented leakage flow inside the extruder barrel may beemployed. The combination of alternating conveying elements withdistributive mixing elements cause the material flow to be continuouslyinterrupted without shearing of the mass thus resulting in mixing of thematerial at low mechanical energy input.

In other embodiments of the invention, other extruder screwconfigurations may be used that facilitate low shear distributivemixing, such as screw elements of the type ZME, TME, SME, and so-calledIGEL elements commercially available from Werner and Pfleiderer.

The total length of the distributive mixing section may be about 3 to 12l/d, preferably about 4 to 6 l/d to sufficiently admix and distributeand embed or encapsulate the added active components in the matrix.

The at least substantially homogeneous mixture of matrix material andadded active ingredient or encapsulant may then be conveyed towards anextruder die plate. The conveying may be achieved by the use of lowpitch extruder screw conveying elements which build up sufficientpressure prior to extruding the mix so that it can be forced through theapertures in the die plate. Another function of the low pitch elementsis that they increase the degree of fill inside the last extruder barrelsection. The increased degree of fill enables control of the temperatureprofile of the mix inside the extruder barrel for achieving optimumviscosity adjustment and extrusion through the subsequent die openings.

The dough or crumbly mass or mix may be extruded or pressed throughextrusion dies having aperture diameters of from about 0.3 mm to about 5mm, preferably from about 0.5 mm to about 3 mm, for example from about0.5 mm to about 1 mm. The diameter of the extrudate rope and product maybe larger than the diameter of the die apertures due to deformation orswelling as the composition exits the die. The increase in diameter uponexiting the die may occur without substantial development of anexpanded, puffed, foamy, or cellular structure. The extruded rope mayhave a cross-sectional diameter of from about 0.5 mm to about 7 mm,preferably from about 0.5 mm to about 5 mm, most preferably from about0.5 mm to about 3 mm.

The extrudate rope may be cut at the die face using a rotating cutter,pelletizer, or rotating knives. In other embodiments, the extrudate ropemay be cut away from the die using conventional cutting or forming meansfor producing pellets or tablets. The cut pieces, pellets, or tablets,may have a length:diameter ratio (l/d ratio) of about 0.5 to 10,preferably about 1.

In accordance with the process of the present invention, the particlesize may be varied to control the surface to volume ratio of the pelletsor pieces for achieving a desired controlled release of the encapsulant.The particle size may be varied, for example, by the use of differentdiameters for the extrusion die openings. Particle size may also bevaried by the use of a variable speed cutter either at the die plate atthe end of the extruder or away from the extruder after the ropes havebeen conveyed for a short distance. By varying the speed of the cutter,the size of the cut pieces may be varied for a given extruderthroughput. The use of a variable cutter which is spaced a shortdistance from the die plate, for example, between about 0.5 meters toabout 5 meters permits further surface cooling, further surface drying,and reduced stickiness to provide better cutting of the ropes intopellets.

In producing products for human or animal consumption, variation ofparticle size to control the surface to volume ratio of the pellets iscritical for achieving a controlled release of the encapsulant duringpassage of the pellets or particles through the mouth, the stomach, andthe intestine. Variation of particle size is also critical forcontrolling the residence time of the pellets inside the stomach. Forexample, particles smaller than 1 mm pass through the stomach orintestine faster than would particles larger than for example 2.5 mm.

After cutting, the resulting pieces or pellets may be dried to asufficiently low moisture content which assures a sufficiently prolongedstorage stability or shelf life. For example, the pellets may be driedto achieve a storage stability or shelf life of at least about sixmonths, preferably at least about twelve months, most preferably atleast about thirty-six months. In embodiments of the present invention,the drying may be performed using conventional drying equipment usingdrying temperatures which do not adversely affect the thermal stabilityof the encapsulants. Exemplary drying temperatures may range from about10° C. to about 50° C., for example about 30° C. The drying may beconducted to achieve a moisture content of less than about 30% byweight, preferably less than about 12% by weight, most preferably lessthan about 10% by weight, for example less than about 8% by weight.

The product may be dried using a conventional fluidized bed or otherconventional drying means. The product may be optionally coated afterdrying using conventional coating equipment such as coating pans,coating drums, or spray devices.

In embodiments where film-building substances or coatings are applied tothe particles or pellets, conventional spray nozzles may be locatedclose to the die for spraying an aqueous or alcoholic solution of thefilm-building substances onto the cut pieces as they fall downwardlyfrom the extruder die. In other embodiments, the film-buildingsubstances may be applied after drying of the pellets. For example, thefilm-building substances may be applied using spray nozzles,conventionally known fluid bed coating apparatus, or other conventionalcoating apparatus and methods. If the application of the film-buildingsubstances increases the moisture content above a shelf stable level,the water or other volatile media may be removed from the surface of theparticles by additional drying.

In embodiments of the present invention, the extruded pieces or pelletsmay be compressed in conventional tablet presses to obtain compressedversions of the extruded pellets.

In other embodiments of the present invention, the mixture may beextruded or formed into bars or into a rope which may be cut into foodbar-sized pieces. The mixture may also be extruded through a sheetingdie into a sheet. The extruded sheet may then be cut or molded intoindividual pieces, such as bars, snack-sized pieces, tablets, or disks,using a rotary die or rotary cutter, or reciprocating cutter orcounterrotating drums conventionally known as agglomeration drums ortableting drums.

The products of the present invention may possess a chewable texture,like that of streusel or chewable vitamin pills with a cookie-liketaste. They may comprise food bar or snack-sized pieces, or they maycomprise discrete particles which may be spherical, lens-shaped, or flatdiscs having diameters of from about 0.5 mm to about 7 mm, preferablyfrom about 0.5 mm to about 5 mm, most preferably from about 1 mm toabout 3 mm, exclusive of any optional exterior film-building substancesor coatings. In embodiments of the invention, the particles of theinvention may be in the form of tablets with diameters of up to about 10mm. The length-to-diameter ratio (l/d) of the particles may be fromabout 0.1 to about 10, for example about 0.5 to about 2, preferablyabout 1. The particles are generally uniform in size, non-glassy, andgranular to increase palatability to humans and animals in asubstantially compact form that is easy to swallow with or withoutchewing. The products of the invention are non-expanded, generally notleavenable, and exhibit a non-puffed, substantially non-cellular,non-glassy structure. The starch component of the matrices may besubstantially ungelatinized, and not substantially destructurized ordextrinized. Exemplary specific densities of the products of the presentinvention are between about 800 g/liter and about 1500 g/liter (about0.8 to about 1.5 g/cm³).

The encapsulated products of the present invention may be incorporatedwith or without grinding into foods intended for human or animalconsumption such as baked goods, for example, bread, wafers, cookies,crackers, pretzels, pizza, and rolls, ready-to-eat breakfast cereals,hot cereals, pasta products, snacks such as fruit snacks, salty snacks,grain snacks, and microwave popcorn, dairy products such as yoghurt,cheese, and ice cream, sweet goods such as hard candy, soft candy, andchocolate, beverages, animal feed, pet foods such as dog food and catfood, aqua-culture foods such as fish food and shrimp feed, and specialpurpose foods such as baby food, infant formulas, hospital food, medicalfood, sports food, performance food or nutritional bars, or fortifiedfoods, food preblends or mixes for home or food service use, such aspreblends for soups or gravy, dessert mixes, dinner mixes, baking mixessuch as bread mixes, and cake mixes, and baking flour.

In preferred embodiments, the active encapsulant is either a livemicroorganism, enzyme, micronutrient, trace element, nutraceuticalcomponent, biologically active material or a combination thereof Theencapsulated product may be redispersed as a liquid, or as a solid forhuman food, animal feed, or pharmaceutical purposes. The products of thepresent invention may be used as or incorporated into foods for specialpurposes, such as performance foods, mood foods, medical foods,nutritional snacks or supplements, sport foods such as power bars, babyfoods, toddler foods, infant foods, or foods for pharmaceutical purposesor other dietetic purposes. The discrete particulates or granules of thepresent invention may be used as a topping for breakfast cereals,snacks, soups, salad, cakes, cookies, crackers, puddings, desserts orice cream. They may also be used as a granular ingredient for yogurts,desserts, puddings, custards, ice cream or other pasty or creamy foods.Regularly sized pieces may be individually packaged or used asnutritional snacks or, for example added to or formed into nutritionalfood in bar form.

The present invention is further illustrated by the followingnon-limiting examples where all parts, percentages, proportions, andratios are by weight, and all temperatures are in ° C. unless otherwiseindicated:

EXAMPLE 1

Production of Good Tasting and Chewable Pellets Having Encapsulated LiveMicroorganism

In this example 10 kg cookies (Leibnitz Keks, Bahlsen, Germany) wereground with a hammer mill into a flour having a particle size of 100%less than 1 mm. This flour was fed at a rate of 4 kg/h into a twin screwextruder (Werner & Pfleiderer, ZSK22). A mix of water and citrus juice(ratio 7:1) was fed at a rate of 0.8 kg/h into the same extruder. 0.188kg of Lactobacillus Acidophilus was preblended with 0.375 kg vegetablefat (BISKIN) and 0.188 kg vegetable oil and the preblend was fed at arate of 0.750 kg/h into a subsequent barrel of the same extruder. Thebarrel temperature of the extruder was kept at 20° C. The extruderconditions were:

rpm 150 revolutions per minute Pressure 45 bar Product Temperature 31°C. Die 20 × 1 mm diameter

The product was cut into individual pellets at the die face with arotating knife. The pellets were dried at 30° C. in a convection batchdryer for 1 hr to 5.9% moisture. The pellets containing liveLactobacilli exhibit a pleasant taste and chewable texture.

EXAMPLE 2

Coating With Thin Additional Coat

A portion of the pellets made in Example 1 were coated with a 25%shellac/alcohol solution to obtain a 5% shellac coat based on the totalweight of the total product. These pellets containing live lactobacilliexhibit a pleasant taste and chewable texture, that was slightly harderthan the uncoated sample, but still chewable and eatable.

EXAMPLE 3

Coating With Thick Additional Coat

Another portion of the pellets obtained in Example 1 were coated with a25% shellac/alcohol solution to obtain a 10% shellac coat based on thetotal weight of the total product. The obtained pellets containing livelactobacilli exhibit a pleasant taste and chewable texture, that wasslightly harder than the 5% coated sample of Example 2, but they werestill chewable and eatable.

COMPARATIVE EXAMPLE

Semolina flour was fed at a rate of 4 kg/h into a twin screw extruder(Werner & Pfleiderer, ZSK22). Water was fed at a rate of 1.5 kg/h intothe same extruder. 0.18 kg of Lactobacillus Acidophilus was preblendedwith 0.36 kg vegetable fat (BISKIN) and 0.18 kg vegetable oil and thepreblend was fed at a rate of 0.72 kg/h into a subsequent barrel of thesame extruder. The barrel temperature of the extruder was kept at 20° C.

The extruder conditions were:

rpm 120 revolutions per minute Pressure 20 bar Product Temperature 29°C. Die 20 × 1 mm diameter

The product was cut into individual pellets at the die face with arotating knife. The pellets were dried at 30° C. in a convection batchdryer for 1 hour to 8.25% moisture.

The pellets containing live lactobacilli exhibit a very hard andunacceptable texture to be eaten as such. The texture was comparable tothat of uncooked pasta.

What is claimed is:
 1. An edible matrix composition that has a chewabletexture and that contains at least one component encapsulated by thematrix composition, said matrix composition comprising at least oneplasticizer, and a free-flowing particulate mixture which comprises atleast one fat, at least one starch, and at least one sugar which havebeen mixed and heated, said at least one starch having a degree ofgelatinization of less than about 50%.
 2. An edible matrix compositionas claimed in claim 1 wherein said free-flowing mixture is obtained bybaking a mixture of said at least one fat, at least one starch, and atleast one sugar without substantially gelatinizing said at least onestarch to obtain a baked product and then grinding the baked product toobtain said free-flowing mixture.
 3. An edible matrix composition asclaimed in claim 1 wherein said free-flowing mixture is ground cookies.4. An edible matrix composition as claimed in claim 1 wherein saidplasticizer comprises a fat or oil.
 5. An edible matrix composition asclaimed in claim 1 wherein said plasticizer comprises water.
 6. Anedible matrix composition as claimed in claim 1 wherein the free-flowingmixture content is at least about 10% by weight, based upon the weightof said edible matrix composition.
 7. An edible matrix composition asclaimed in claim 4 wherein the plasticizer content is from about 10% byweight to about 70% by weight, based upon the total weight of saidfree-flowing mixture and said plasticizer.
 8. An edible matrixcomposition as claimed in claim 1 wherein the plasticizer content is upto about 90% weight, based upon the weight of said edible matrixcomposition.
 9. An edible matrix composition as claimed in claim 1wherein the plasticizer comprises oil or fat, and the oil or fatplasticizer content is up to 90% by weight, based upon the weight ofsaid edible matrix composition.
 10. An edible matrix composition asclaimed in claim 9 wherein the melting point of said oil or fatplasticizer is at least about 30° C.
 11. An edible matrix composition asclaimed in claim 5 wherein the moisture content of the edible matrixcomposition is less than about 8% by weight, based upon the weight ofthe matrix composition.
 12. An edible matrix composition as claimed inclaim 1 wherein said at least one component is selected from the groupconsisting of biologically active components, pharmaceutical components,nutraceutical components and microorganisms.
 13. An edible, chewablematrix composition as claimed in claim 1 wherein the starch content ofthe matrix composition consists essentially of the starch content ofsaid free-flowing mixture.
 14. An edible matrix composition as claimedin claim 3 wherein said ground cookies comprise from about 8% by weightto about 40% by weight shortening or fat, from about 15% by weight toabout 40% by weight sugar, and from about 20% by weight to about 75% byweight flour, based upon the weight of the ground cookies.
 15. An ediblematrix composition as claimed in claim 1 wherein said at least onecomponent comprises live probiotic microorganisms.
 16. An edible matrixcomposition as claimed in claim 15 wherein said at least one componentcomprises live lactobacilli.
 17. An edible matrix composition as claimedin claim 12 which is coated with a coating composition in an amount offrom about 0.5% by weight to about 50% by weight, based upon the weightof the coated product.
 18. An edible chewable matrix composition asclaimed in claim 1 further including at least one flavor or textureenhancing ingredient selected from the group consisting of chocolate,flavors, concentrated juices, fibers, and compound coatings.
 19. Anedible matrix composition as claimed in claim 18 wherein said at leastone flavor or texture enhancing ingredient is selected from the groupconsisting of emulsifiers, oils and fats.
 20. An edible matrixcomposition according to claim 3 wherein said ground cookies contain atleast one component selected from the group consisting of high fructosecorn syrup, maltodextrins, corn syrup, dextrose, lactose, maltose,modified or unmodified starches, leavening agents, non-fat dry milk,full fat dry milk, whey, gluten, soluble and insoluble fiber, nutrients,inulin, hydrocolloids, dry eggs, salt, flavor, emulsifier, cocoa, andcocoa butter.
 21. An edible and chewable product comprising: a) afree-flowing particulate mixture which comprises at least one fat, atleast one starch, and at least one sugar which have been mixed andheated, said at least one starch having a degree of gelatinization ofless than about 50%, and b) an encapsulant, wherein the encapsulant isembedded or encapsulated in a dough made substantially from thefree-flowing mixture and a plasticizer, said dough being dried to ashelf-stable moisture content.
 22. An edible and chewable product asclaimed in claim 21 wherein said free-flowing mixture comprises a flourobtained by grinding cookies.
 23. An edible and chewable product asclaimed in claim 21 wherein said encapsulant comprises at least onemember selected from the group consisting of biologically activecomponents, neutraceutical components, and live microorganisms.
 24. Anedible and chewable product as claimed in claim 21 wherein saidencapsulant is pre-encapsulated.
 25. An edible and chewable product asclaimed in claim 21 wherein said encapsulant is heat sensitive.
 26. Anedible and chewable product as claimed in claim 21 wherein saidencapsulant has an undesirable taste which is masked by saidfree-flowing mixture.
 27. An edible and chewable product as claimed inclaim 21 which is coated with a coating composition.
 28. An edible andchewable product as claimed in claim 21 which is a food bar.
 29. Anedible and chewable product as claimed in claim 21 which is in granularform.
 30. A food composition comprising an edible and chewable productas claimed in claim 21 which is selected from the group consisting ofready-to-eat breakfast cereals, snacks, soups, salads, cakes, cookies,crackers, puddings, ice creams, yogurts, puddings, custards, baby foods,medicinal foods, sports bars, and beverages.
 31. A food composition asclaimed in claim 30 which is a yogurt, pudding, custard, or ice creamwherein said edible and chewable product is in granular form.
 32. A foodcomposition as claimed in claim 30 which is a breakfast cereal, snack,soup, salad, cake, cookie, cracker, yogurt, pudding, custard, or icecream wherein said edible and chewable product is applied as a topping.33. A food composition as claimed in claim 30 which is a beverage.
 34. Afood composition comprising a topping which is an edible and chewableproduct as claimed in claim
 30. 35. A food topping comprising an ediblematrix composition as claimed in claim 1 in granular form.
 36. Anedible, chewable matrix composition comprising: a liquid plasticizer, anencapsulant, and a flour comprising ground cookies, wherein the starchcontent of the matrix composition has a degree of gelatinization of lessthan about 50% so as to provide a chewable, non-glassy texture to thematrix composition, and wherein the encapsulant is encapsulated byplasticized ground cookies.
 37. An edible, chewable matrix compositionas claimed in claim 36 wherein said encapsulant comprises at least onemember selected from the group consisting of biologically activecomponents, pharmaceutical components, neutraceutical components andmicroorganisms.
 38. An edible, chewable matrix composition as claimed inclaim 36 wherein the amount of said ground cookies is at least about 10%by weight of said chewable matrix composition.
 39. An edible, chewablematrix composition as claimed in claim 36 wherein the moisture contentof the chewable matrix composition is less than about 8% by weight,based upon the weight of the matrix composition.
 40. An edible, chewablematrix composition as claimed in claim 36 which is in particulate form.41. An edible, chewable matrix composition as claimed in claim 36wherein the starch content of the matrix composition consistsessentially of the starch content of said ground cookies.
 42. A methodfor the manufacture of edible products containing an encapsulatedcomponent comprising: a) mixing a free-flowing particulate mixture witha plasticizer to obtain a crumbly mass or dough, said free-flowingmixture comprising a flour made from at least one fat, at least onestarch, and at least one sugar which have been mixed and heated so thatsaid at least one starch has a degree of gelatinization of less thanabout 50%, b) admixing at least one encapsulant into the crumbly mass ordough, c) compressing the crumbly mass or dough to obtain a compresseddough, d) shaping the compressed dough, and e) separating the shapeddough into individual pieces, wherein ingredients comprising thefree-flowing mixture, plasticizer, and encapsulant are admixed,compressed and shaped at temperatures sufficiently low so as to preventthermal degradation of the encapsulant and at pressures sufficientlyhigh to enable the formation of coherent pieces.
 43. A method as claimedin claim 42 wherein at least said mixing is performed in a continuousmixer or in a twin screw extruder.
 44. A method as claimed in claim 42wherein the compressed dough is shaped by extrusion.
 45. A method asclaimed in claim 42 wherein said free-flowing mixture is obtained bybaking a mixture of said at least one fat, at least one starch, and atleast one sugar without substantially gelatinizing said at least onestarch to obtain a baked product and then grinding the baked product toobtain said free-flowing mixture.
 46. A method as claimed in claim 42wherein said free-flowing mixture is ground cookies.
 47. A method asclaimed in claim 42 wherein said plasticizer comprises at least onemember selected from the group consisting of fats, oils, and water. 48.A edible matrix composition as claimed in claim 42 wherein saidplasticizer comprises fat or oil.
 49. A method as claimed in claim 42wherein said free-flowing mixture comprises a flour obtained by grindingcookies to a particle size of less than about 5 mm.
 50. An edible matrixcomposition as claimed in claim 1, wherein said at least one componentcomprises a pharmaceutical composition, a nutraceutical composition, aflavorant, or a fragrance.
 51. An edible matrix composition having achewable texture comprising: a matrix comprising at least oneplasticizer and a free-flowing particulate mixture, said free-flowingmixture comprising at least one fat, at least one starch, and at leastone sugar which have been mixed and heated without substantiallygelatinizing said at least one starch; and at least one componentencapsulated by the matrix and selected from the group consisting ofanalgesics, anti-inflammatory agents, anti-depressants, anti-viralagents, anti-tumor agents, enzyme inhibitors, steroids, hormones, HIVprotease inhibitors, and mixtures thereof.
 52. An edible matrixcomposition having a chewable texture comprising: a matrix comprising atleast one plasticizer and a free-flowing particulate mixture, saidfree-flowing mixture comprising at least one fat, at least one starch,and at least one sugar which have been mixed and heated withoutsubstantially gelatinizing said at least one starch; and at least onecomponent encapsulated by the matrix and selected from the groupconsisting of antioxidants, phytochemicals, vitamins, folic acid,pantothenate, minerals, fatty acids, enzymes, amino acids, and mixturesthereof.
 53. An edible matrix composition having a chewable texturecomprising: a matrix comprising at least one plasticizer and afree-flowing particulate mixture, said free-flowing mixture comprisingat least one fat, at least one starch, and at least one sugar which havebeen mixed and heated without substantially gelatinizing said at leastone starch; and an omega-3 fatty acid encapsulated by the matrix.
 54. Anedible matrix composition according to claim 1, wherein said at leastone starch has a degree of gelatinization of less than about 30%.
 55. Anedible matrix composition according to claim 1, wherein said at leastone starch has a degree of gelatinization of less than about 15%.
 56. Anedible matrix composition according to claim 1, wherein said at leastone plasticizer is selected from the group consisting of a sugarsolution, juice, alcohol, glycerol, and sorbitol.
 57. An edible matrixcomposition according to claim 1, wherein said at least one plasticizeris an alcohol.
 58. An edible and chewable product according to claim 21,wherein said at least one starch has a degree of gelatinization of lessthan about 30%.
 59. An edible and chewable product according to claim21, wherein said at least one starch has a degree of gelatinization ofless than about 15%.
 60. An edible, chewable matrix compositionaccording to claim 36, wherein the starch content of the matrixcomposition has a degree of gelatinization of less than about 30%. 61.An edible, chewable matrix composition according to claim 36, whereinthe starch content of the matrix composition has a degree ofgelatinization of less than about 15%.
 62. A method according to claim42, wherein said free-flowing mixture comprises a flour made from atleast one fat, at least one starch, and at least one sugar which havebeen mixed and heated so that said at least one starch has a degree ofgelatinization of less than about 30%.
 63. A method according to claim42, wherein said free-flowing mixture comprises a flour made from atleast one fat, at least one starch, and at least one sugar which havebeen mixed and heated so that said at least one starch has a degree ofgelatinization of less than about 15%.
 64. An edible matrix compositionaccording to claim 51, wherein said at least one starch has a degree ofgelatinization of less than about 50%.
 65. An edible and chewableproduct according to claim 52, wherein said at least one starch has adegree of gelatinization of less than about 50%.
 66. An edible andchewable product according to claim 53, wherein said at least one starchhas a degree of gelatinization of less than about 50%.
 67. An ediblematrix composition that has a chewable texture, comprising: a matrixcomprising at least one plasticizer, and a free-flowing particulatemixture which comprises at least one fat, at least one starch, and atleast one sugar which have been mixed and heated, said at least onestarch having a degree of gelatinization of less than about 30%; andlactobacillus encapsulated by the matrix.